Novo Nordisk is finally facing some major competition to its obesity franchise juggernaut, now that Eli Lilly’s rival therapy tirzepatide has been approved by the FDA as a weight-loss drug.

诺和诺德终于面临着肥胖特许经营juggernaut的一些重大竞争，因为礼来公司的竞争对手疗法tirzepatide已被FDA批准为减肥药。

Already a blockbuster as a therapy for type 2 diabetes under the Mounjaro brand name, dual GLP-1/GIP agonist tirzepatide has been cleared for obesity as Zepbound, paving the way for a big increase in sales and setting up a battle for market share with Novo Nordisk’s GLP-1 agonist Wegovy (semaglutide)..

作为Mounjaro品牌的2型糖尿病治疗药物，双GLP-1/GIP激动剂tirzepatide已经被Zepbound清除为肥胖，为大幅增加销售额铺平了道路，并与市场份额斗争诺和诺德的GLP-1激动剂Wegovy（semaglutide）。。

The FDA has approved Zepbound for chronic weight management in adults who are obese with a body mass index of 30 or more, or overweight with a BMI of at least 27 and at least one weight-related health condition, such as high blood pressure, high cholesterol and/or diabetes.

FDA已批准Zepbound用于体重指数为30或更高的肥胖成年人的慢性体重管理，或超重且BMI至少为27且至少有一种体重相关的健康状况，如高血压，高胆固醇和/或糖尿病。

That is the same indication as Wegovy when it was first approved by the FDA for obesity in 2021, although Novo Nordisk’s drug has since had its label extended to include obese adolescents aged 12 and over. Both drugs are given as subcutaneous injections once weekly.

这与Wegovy在2021年首次被FDA批准用于肥胖时的迹象相同，尽管诺和诺德药物的标签已经扩展到包括12岁及以上的肥胖青少年。两种药物每周一次皮下注射。

Lilly said Zepbound should be launched before the end of the year, with a wholesale price of $1,060 for a month’s supply, a discount on Wegovy’s price of around 1,350 ahead of discounts.

礼来表示，Zepbound应在年底前推出，一个月供应的批发价格为1060美元，Wegovy价格折扣约1350，折扣前。

It expects patients with insurance and obesity drug coverage to pay as little as $25 out-of-pocket for a one- or three-month prescription and said people whose insurance does not cover this category will be eligible for a 50% discount on the list price at $550 per month.

它预计保险和肥胖药物保险的患者可以在一个月或三个月的处方中自付低至25美元的费用，并且表示保险不包括此类别的人将有资格在标价上享受50%的折扣每月$550。

“Far too many hurdles continue to prevent people living with obesity from accessing obesity treatments that could lead to significant weight loss,” said Mike Mason, head of diabetes and obesity at Lilly.

礼来公司糖尿病和肥胖症负责人Mike Mason说：“太多障碍继续阻止肥胖患者获得可能导致体重明显减轻的肥胖治疗。

“Broader access to these medicines is critical, which is why Lilly is committed to working with healthcare, government and industry partners to ensure people who may benefit from Zepbound can access it,” he added.

他补充说：“更广泛地获得这些药物至关重要，这就是为什么礼来公司致力于与医疗保健，政府和行业合作伙伴合作，确保可能从Zepbound中受益的人能够获得这些药物。”。

There has already been considerable off-label prescribing of Mounjaro for weight loss as well as Novo Nordisk’s Ozempic, the formulation of semaglutide indicated for diabetes, and all three drugs have been affected by supply constraints.

Mounjaro已经有相当多的标签外处方用于减肥，以及诺和诺德的Ozempic，用于糖尿病的semaglutide配方，并且所有三种药物都受到供应限制的影响。

In its third-quarter update earlier this month, Lilly said supplies of tirzepatide would remain “tight” for the foreseeable future but was working to double capacity by the end of the year.

在本月早些时候的第三季度更新中，礼来表示，在可预见的将来，替泽帕肽的供应量将保持“紧张”，但到年底将使产能翻一番。

Despite those constraints, Zepbound is expected to make rapid inroads into the market for obesity drugs, not least because it generated very impressive weight-loss results in clinical trials, achieving an average weight loss of around 16% to 22.5% of total body weight, while in Novo Nordisk’s pivotal trials the average reduction was in the range of 10% to 16%.

尽管存在这些限制，但预计Zepbound将迅速进入肥胖药物市场，尤其是因为它在临床试验中产生了非常令人印象深刻的减肥效果，平均体重减轻约占总体重的16%至22.5%，而在诺和诺德的关键试验中，平均减少幅度在10%至16%之间。

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That comparison comes however with the usual caveat that trying to compare the outcomes of trials with different protocols is fraught with difficulty.

然而，这种比较伴随着通常的警告，即试图比较不同方案的试验结果充满困难。

On the other hand, in Novo Nordisk’s favour is that it already has clinical data showing that the weight loss achieved with Wegovy translates to a reduced risk of cardiovascular disease, while Lilly isn’t expecting results from a similar outcomes study until 2027.

另一方面，诺和诺德赞成的是，它已经有临床数据显示，Wegovy所达到的体重减轻可以降低心血管疾病的风险，而礼来公司预计到2027年才会有类似的结果研究结果。

Losing 5% to 10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in adults who are obese or overweight, but some insurance companies have baulked at providing coverage for the drugs, saying the cost is too great unless there is clear evidence of health benefits beyond weight loss..

通过饮食和运动减轻5%至10%的体重与肥胖或超重的成年人患心血管疾病的风险降低有关，但一些保险公司拒绝提供药物保险，表示费用太高除非有明确的证据表明体重减轻以外的健康益处。。

Lilly is also running a head-to-head study that will pit the two rival drugs directly against each other, hoping to mirror another study in diabetes that showed Mounjaro was more effective than Ozempic in diabetes.

礼来公司也在进行一项头对头的研究，将两种对立的药物直接相互对抗，希望能够反映另一项糖尿病研究，显示Mounjaro在糖尿病方面比Ozempic更有效。

In a statement, the director of the FDA’s division of diabetes, lipid disorders and obesity – John Sharretts – said that tirzepatide’s approval addresses an “unmet medical need” given the increasing rates of obesity and overweight in the US.

在一份声明中，FDA糖尿病，脂质紊乱和肥胖症司主任John Sharretts表示，鉴于美国肥胖和超重率的上升，tirzepatide的批准解决了“未满足的医疗需求”。

Approximately 70% of American adults are obese or overweight, and many of those also have a weight-related condition. Analysts have suggested that the market for weight-loss drugs, driven by GLP-1 therapies, could reach $100 billion a year by 2030.

大约70%的美国成年人肥胖或超重，其中许多人也有体重相关的疾病。分析师表示，到2030年，由GLP-1疗法驱动的减肥药市场每年可能达到1000亿美元。